
Cognito Therapeutics has unveiled promising new findings from its OVERTURE feasibility trial, highlighting the potential of its investigational therapy, Spectris AD, to decelerate the progression of Alzheimer’s disease.
The therapy utilises non-invasive neuromodulation by synchronising light and sound stimulation at a gamma frequency of 40Hz to restore disrupted brain electrical activity associated with Alzheimer’s.
The latest post hoc analysis, published in Alzheimer’s & Dementia: Translational Research and Clinical Interventions, demonstrates that Spectris AD therapy is linked to significant “time saved” in cognitive functions, daily activities, and brain structure preservation when compared to a sham treatment. This “time saved” metric quantifies the extended duration treated patients maintain essential functions before experiencing the level of decline typical in untreated individuals.
Cognito CEO Christian Howell said: “Our brains are electrical systems, and Alzheimer’s disrupts the rhythms that govern memory, cognition, and our ability to function.
“Spectris AD represents a new class of therapy, one based in physics, that restores these natural neural oscillations without relying on a chemistry-based pharmacologic therapy. These findings show the potential to meaningfully slow disease progression by leveraging the potential of neuromodulation.”
The OVERTURE trial involved 76 participants with mild-to-moderate Alzheimer’s disease undergoing a six-month randomised controlled phase, followed by a 12-month open-label extension.
Initial results show that daily one-hour sessions with Spectris AD resulted in 4.83 months of preserved daily function, a 4.56-month delay in cognitive decline, and a 4.09-month delay in whole-brain atrophy.
Over the entire 12-month study period, these benefits became more evident, as those treated with Spectris AD showed significantly delayed disease progression compared to those receiving sham treatment.
Participants initially assigned to Spectris AD and continuing in the open-label extension exhibited prolonged cognitive and functional abilities beyond the six months observed in the control group.
Currently under evaluation in the HOPE pivotal clinical trial, Spectris AD is designed for simple daily use at home and has been recognised with breakthrough device designation by the US Food and Drug Administration (FDA).
In OVERTURE, the therapy demonstrated a favourable adverse event profile, adherence rates exceeding 80%, and no observed risk of ARIA.
Cognito Therapeutics is advancing Spectris as part of a broader clinical platform that integrates physics, neuroscience, and clinical engineering to develop novel therapeutic interventions for neurodegenerative diseases.
Ongoing studies aim to expand understanding of non-invasive gamma stimulation’s effects on brain structure, immune pathways, and connectivity to potentially alter neurodegenerative disease trajectories on a wider scale.